Recall Z-2105-2008 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corp
Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210. System is used for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.
| Date | Sep 11, 2008 (initiated Apr 2, 2008) |
| Status | Terminated |
| Reason | Rapid Exchange Biliary Stent may be mislabeled as Flexima biliary Stent, which has a different delivery system included in the package. |
| Root cause | Packaging process control |
| Action | An Urgent Medical Device Recall-Immediate Action Required letter was sent to consignees on 4/2/08 directing them to immediately discontinue use of and segregate the identified products for return to the firm and complete the verification tracking form. |
| Quantity | 80 |
| Distribution | Class III Recall - Worldwide Distribution --- including USA and countries of Finland, France, Germany and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965147 | BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS Boston Scientific Corp, Jun 30, 1997 |